medical Class II Updated 2023-07-26

MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel,

Recalled Product

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) RADIAL ARTERIAL LINE KIT, Model Number ART1070A; b) ARTERIAL LINE START KIT, Model Number ART1160; c) ARTERIAL LINE TRAY W/O CATHETER, Model Number ART1180; d) ARTERIAL LINE INSERTION KIT, Model Number ART775B; e) ARTERIAL LINE KIT W/O CATHETER, Model Number ART890A; f) ARTERIAL BUNDLE NO CATHETER, Model Number ART995; g) ARTERIAL LINE START KIT W/O CATH, Model Number P42453;

Hazard / Issue

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: all lots within expiry, distributed from Medline between December 2017 May 2023: a) Model Number ART1070A, UDI/DI EA 10653160358329, UDI/DI CS 00653160358322; b) Model Number ART1160, UDI/DI EA 10653160355762, UDI/DI CS 00653160355765; c) Model Number ART1180, UDI/DI EA 10653160355472, UDI/DI CS 00653160355475; d) Model Number ART775B, UDI/DI EA 10653160353560, UDI/DI CS 00653160353563; e) Model Number ART890A, UDI/DI EA 10653160356677, UDI/DI CS 00653160356670; f) Model Number ART995, UDI/DI EA 10193489190502, UDI/DI CS 20193489190509; g) Model Number P42453, UDI/DI EA 10653160323792, UDI/DI CS 00653160323795

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